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Tandem Melphalan and Autolog. SCT in MM Patients 60 to 70 Years of Age With and Without Induction Chemotherapy

NCT02288741 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 549

Last updated 2014-11-11

No results posted yet for this study

Summary

Patients 60 to 70 years of age with newly diagnosed multiple myeloma were prospectively randomized between 4 cycles of anthracycline/dexamethasone-based induction chemotherapy (A1) or only 2 x 4 days of dexamethasone (A2). A reference arm included patients who could not be randomized (B). Tandem melphalan 140 mg/m² (MEL140) with autologous transplantation was scheduled for all patients.

Conditions

Interventions

DRUG

Anthracycline/dexamethasone-based induction chemotherapy

4 cycles of anthracycline/dexamethasone-based chemotherapy

DRUG

Dexamethasone for control of symptoms

2 x 4 days of dexamethasone (day 1-4 and day 8-11: 40mg)

DRUG

Tumor-reduction chemotherapy and stem cell mobilization

Ifosfamide (day 1-3: 1.900mg/m² iv), epirubicin (day 1: 75 mg/m² iv), etoposide (day 1-3: 120 mg/m² iv) and G-CSF (day 5 until end of apheresis: 5µg/kg sc)

PROCEDURE

Stem cell apheresis

stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 \* 10E6/kg

DRUG

Tandem high-dose chemotherapy (melphalan)

Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)

PROCEDURE

Autologous peripheral blood stem cell transplantation

Two infusions of collected stem cells (day 0: 2\*10E6 CD34-cell/kg per transplantation)

Sponsors & Collaborators

  • WiSP Wissenschaftlicher Service Pharma GmbH

    lead OTHER

Principal Investigators

  • Christian Straka, Prof. Dr. · Schön Klink Starnberger See

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2012-09-30
Completion
2012-09-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02288741 on ClinicalTrials.gov